The U.S. Food and Drug Administration (FDA) has announced a proposed rule that aims to standardize testing methods for detecting and identifying asbestos in talc-containing cosmetic products. This move is designed to protect consumers from potential exposure to asbestos, a known carcinogen, in products that contain talc—a mineral frequently used in cosmetics for its ability to absorb moisture and improve texture.
As part of its ongoing efforts under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the FDA is pushing for stricter regulations that require manufacturers to use specific analytical techniques. These techniques include Polarized Light Microscopy (PLM) with dispersion staining, and Transmission Electron Microscopy (TEM) combined with Energy Dispersive Spectroscopy (EDS) and Selected Area Electron Diffraction (SAED). Alternatively, manufacturers can choose to rely on a certificate of analysis provided by their talc supplier. FDA Mandates Talc Testing in Cosmetics.
This proposed rule highlights the FDA’s commitment to consumer safety, especially given the fact that talc deposits are often located in close proximity to asbestos. This geographical overlap raises the risk of contamination during the mining process. “We have carefully considered the scientific evidence and complex policy issues related to detecting and identifying asbestos in talc and talc-containing cosmetic products,” said Linda Katz, M.D., M.P.H., director of the FDA’s Office of Cosmetics and Colors. FDA Mandates Talc Testing in Cosmetics.
Under the proposed rule, manufacturers will be required to keep detailed compliance records. If asbestos is detected in talc-containing products, these products would be considered adulterated and therefore subject to regulatory action under the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA Mandates Talc Testing in Cosmetics.
The FDA is now inviting public feedback on this proposal, with a comment period open for 90 days after its publication in the Federal Register. Once the comment period concludes, the agency will review the input and finalize the rule, reinforcing its commitment to enhancing consumer safety in the cosmetics industry.
